FDA product code FDY: Device, Measuring, For Panendoscope
FDY is the FDA product code for device, measuring, for panendoscope. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. Devices under FDY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Device, Measuring, For Panendoscope |
| Device class | Class I |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for FDY devices
openFDA lists no recalls for product code FDY.
Frequently asked questions
What is FDA product code FDY?
FDY is the FDA product code for device, measuring, for panendoscope. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FDY?
Class I, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code FDY
- Run a recall and safety report across every FDY manufacturer
- Watch product code FDY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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